Drug Safety Labeling Changes - January  2012

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Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions

Drug Name Sections Modified
C W P AR
Aliskiren - - - -
Aliskiren and Amlodipine - -
Aliskiren and hydrochlorothiazide - -
Aliskiren and valsartan - -
Aliskiren, Amlodipine and Hydrochlorothiazide - -
Amlodipine , Hydrochlorothiazide and Olmesartan - -
Amlodipine and Benazepril - -
Amlodipine and Olmesartan - -
Amlodipine and Valsartan - -
Amlodipine, Valsartan and Hydrochlorothiazide - -
Azacitidine - - -
Azelastine - - -
Benazepril - -
Benazepril HCl and Hydrochlorothiazide - -
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets - -
Bromocriptine - - -
Bupivacaine hydrochloride and epinephrine bitartrate injection - - - -
Bupropion - - -
Ceftriaxone for Injection and Dextrose Injection in Duplex Container -
Cetuximab - -
Clindamycin
Clozapine -
Colesevelam Hcl - - -
Dabigatran - -
Darifenacin - - -
Dronedarone - - -
Eprosartan - -
Eprosartan Mesylate Hydrochlorothiazide - -
Esomeprazole -
Ezetimibe - - -
Ezetimibe and simvastatin -
Fenofibric Acid - - -
Formoterol -
Gabapentin - -
Hydroxyurea - - -
Iloperidone - -
Irbesartan - -
Irbesartan and Hydrochlorothiazide - -
Leuprolide - - -
Marcaine and Marcaine with Epinephrine Injection - - -
Marcaine Spinal Injection - - - -
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets - -
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, and 80/12.5 mg, and 80/25 mg Tablets -
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets -
Moexipril HCl Hydrochlorothiazide Tablets - - - -
Morphine -
Nafarelin - - -
Naproxen and Esomeprazole Magnesium -
Orlistat -
Quinapril - -
Quinapril HC- Hydrochlorothiazide Tablets - -
Ramipril - -
Solifenacin - - -
Telmisartan - -
Telmisartan and Amlodipine - -
Trandolapril - -
Trandolapril- Verapamil - -
Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets - - -
Valsartan - -
Valsartan and Hydrochlorothiazide - -
Varenicline -
Zonisamide - - -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

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